Urgent Recruitment to United States - 2017
















Senior / QC Specialist (ELISA exp preferred)
Description:
At GlaxoSmithKline (GSK) we are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world’s leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business.

We are proud of the difference we make and in 2016, FORTUNE Magazine ranked GSK #1 on its list of companies that are changing the world. The 'Change the World' list recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. Put simply, our focus is on improving access and affordability of medicines, regardless of where people live or their ability to pay.
 


GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.
Qualifications:
•       University degree in a relevant science discipline
•       At least 1 year of experience with ELISA
•       Preferably with laboratory experience (advantage)
Technical
•       Competent technical skills in the followings:
-       Common laboratory techniques (advantage)
-       laboratory equipment qualification
-       method validation
-       computer system validation
•       Knowledge of cGLP & cGMP
•       Preferably with knowledge of statistics (advantage)
•       Preferably with SAP knowledge (advantage)

Business
•       Effective report writing skills
•       Planning and Organizing skills
•       Good interpersonal and communication skills
•       Effective team player
•       Leadership skills
•       Analytical skills with logical thinking
•       Conflict management skills
 

Senior Utility and Facility Engineer
Description:
Job Purpose 位目的:
     To technically support the Utility & Facility Operations in managing the cost effective, energy efficient, safe and compliant supply of all Utilities service meet all customer and regulatory requirements including EHS, GMP, Engineering, etc.
      To support annual GMP, Engineering and EHS objectives

Key Responsibilities主要职责:
Managing the secure supply of all utilities on site.
     As a system owner to be responsible for Utility & Facility system which owned keeping normal operation and proper maintenance
      Energy consumption and conservation on the site.
      Engineering compliance including EHS & GMP, local legislation and GSK Engineering standards.
      Draft, review and execute related Utility validation documentation for Engineering. (URS, PIP, IQ, OQ, etc.).
      Make and improve operation and maintenance SOP.
      Through implementation of PM items to ensure minimum engineering related downtime on manufacturing and packaging machinery.
      Responsible for all utility equipment procurement and installation of spare parts.
      Responsible for contacting any external suppliers whose scope of work falls within production machines.
      Responsible for improvement utility equipment.
      Responsible for owned system budget control
      Train the on-shift contractors
      Support technical part in CAPEX project
      Maintenance lifecycle management
      Apply proper tools in incident investigation and CAPA.
      Validation for GMP system
     Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
 


Senior Clinical Research Associate
Description:

The  Clinical Research Associate (CRA) position focuses on the coordination of all activities required to evaluate, initiate, monitor and close clinical trial sites in accordance with regulations. 
Perform all site development, site set-up, site monitoring, and site close-out activities for specific clinical trial investigator sites in accordance with customer expectations, GSK operating standards, and good clinical practices.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Assist in developing the field monitoring organization characterized by process standardization, best practice sharing, and continuous improvement.
Function as the primary site contact between the site staff (i.e., Principal Investigator, Study Coordinator) and GSK.  Cultivates and maintains strong working relationships and communication with investigators and GSK staff.
Assume a greater leadership role in the development and implementation of efficient and effective approaches to study site management (e.g. training co-workers and/or contract monitors; coaching/mentoring monitoring colleagues and study staff, as appropriate;
Provides training, delegated by the Monitoring Manager, for new monitoring personnel and contributes to their performance appraisals, as appropriate.
Takes a leadership role within monitoring organization through assisting with clinical projects, as appropriate. 
Represents US Monitoring / Global Clinical Operations on internal and external process improvement teams.  Takes leadership role when participating in process teams on behalf of the Monitoring organization.
Acts as a resource for other monitoring personnel regarding study-specific knowledge, as well as monitoring issues.
Independently complete special projects as assigned by Monitoring management.
Perform the following routine clinical trial site monitoring functions:
-Monitor compliance with study protocol, CFR,     GCP/ICH and overall clinical objectives.
-Ensure clinical trial site training records are current and maintained as required.
-Verify adequacy of clinical data through comparison of case report forms to source documents.
-Perform CRF review, query generation and resolution against established data review guidelines
-Confirms appropriate management of investigational product by performing drug reconciliation and accountability and other related -Review research specimen sample shipments to central lab.
-On-going review of site regulatory file for completeness and accuracy.
-Track and report progress of study, including activities.
patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance, subject safety and data quality.
-Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan.
-Assist with development of clinical trial specific documents such as Monitoring Plan, CRF Completion Guidelines, etc.
-Manage multiple timelines/deadlines to meet study milestones. 
-Participate in Quality Plan activities, including management of activities to ensure quality outcomes.
 

qualifications:
Bachelor’s Degree in Life Science or professional degree in life science/ medical background/equivalent expertise.   A minimum of 5 years of relevant experience working on clinical trials with a minimum of 2 years monitoring experience.  
Consistently displays excellence in communication skills of a top level CRA
Exhibits ability to identify and interpret problems, recommend creative solutions, and influence appropriate changes.
Demonstrates diligent and self-motivated approach to working in an off-site and independent working environment.
Demonstrates above average ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
Exhibits enhanced awareness of site dynamics and demonstrates ability to motivate, persuade, and educate site personnel.
Travel, including air travel is an essential function of the job – up to 80%.
Valid driver’s license

Medical Information Scientist
Description:
      For assigned products, provide sound medical advice for materials related to a GSK product or related disease state for medical accuracy and scientific balance so as to minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics.
      Provide insight, judgment, creative solutions and sound decisions, at times in the moment, on promotional programs and tactics for assigned products.
     With limited supervision, actively collaborate within matrix team to recommend appropriate creative solutions and /or actions for proposed advertising and promotion sometimes with little or no precedent.
      Requires strong verbal and written communication skills; strong interpersonal skills; good listening skills; flexible thinking; demonstrated ability to influence and collaborate with others; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions and at times facilitate decisions in the moment based on Medical and Pharmaceutical experience.
      This role will be 100% dedicated to provide promotional review support in a collaborative matrixed team for a high volume and agile, multi-channel digital promotion/marketing work stream.
      This role will work within a co-located matrix team with 50% travel primarily within state of NC
 


qualifications:
      Doctor of Pharmacy
      2-3 years of Medical Affairs review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents
      Demonstrated experience in the practice of multi-channel digital promotion review and related requirements to comply with FDA laws and regulations
      5+ years’ experience in clinical practice setting in situations where direct and/or indirect decision making authority for patient care was demonstrated (e.g. direct patient care, treatment protocol development, drug therapy guidelines development, traditional clinical pharmacy practice settings) or within a pharmaceutical industry where medical information (e.g. drug information residency) is verbally shared with healthcare professions.
      Competencies to include: understanding of scientific literature analysis to support the provision of medical engagement through written or verbal communication. Communication and presentation skills. Ability to work independently and manage/prioritize multiple projects simultaneously
      Residency and/or post-doctoral training in a clinical practice/pharmaceutical industry setting
     3+ years of Medical Affairs review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents
      Demonstrated experience in the practice of multi-channel digital promotion review and related requirements to comply with FDA laws and regulations
      Demonstrated understanding of the drug development process
      Demonstrated history of successful interactions with highly matrixed team
      Demonstrated ability to work independently and manage/prioritize multiple projects simultaneously
 

Associate Scientist
Description:
      Participate as a member of the group responsible for generating cell lines to produce biopharm drug substance. 
     Display high motivation to conduct CHO cell line development as well as host/vector engineering in order to deliver high quality and yield products or improve the robustness of platform technologies. 
      Ensure high quality experimental design and operation, data analysis, troubleshooting, and maintenance of detailed records for project reports. 
      Effectively collaborate within a matrixed environment. 
      Deliver high quality work using strong communication skills.

qualifications:
      Bachelor’s degree in biological sciences, biochemistry, or a closely related scientific discipline 
      Minimum two years of experience in related field
     Basic knowledge and strong interests in:  i) molecular & cellular biology of mammalian cells;  ii) recombinant protein expression; iii) modern technologies applied to cell line characterization such as flow cytometry and genome editing.
Preferred qualifications:
      Master’s degree in biological sciences, biochemistry, or a closely related scientific discipline
     Experience with mammalian cell culture and cell line development for recombinant gene expression, including routine cell passage, plasmid construction and purification, transfection and cell line characterization
      Knowledge of equipment and procedures such as auto-cell counting, FACs cell sorting and imaging, and protein analysis
      Excellent interpersonal, organizational, verbal and written communication

Practicante de Calidad Local
Description:
Somos una compañía global enfocada en el cuidado de la salud y liderada por la ciencia. Tenemos la misión de querer ayudar a las personas a hacer más, sentirse mejor y vivir más tiempo.
Realizamos investigación y desarrollo de productos innovadores, como vacunas, medicinas y productos de consumo orientados a la salud.
En más de 115 países, GSK tiene un gran compromiso para mejorar la salud a través del desarrollo de innovadoras medicinas y ampliando el acceso a ellas alrededor del mundo. En más de 300 años de historia, invertimos en innovación para mejorar la vida de las personas.
Como empleado GSK te inspirarás haciendo la diferencia y jugando un papel importante en el beneficio de millones de pacientes y consumidores a nivel mundial.
Con compromiso, integridad y respeto por las personas; trabajarás en un ambiente sano y sostenible, generando un impacto en la comunidad.
Como empleado, en nuestro ambiente inclusivo, te sentirás valorado, motivado y capaz de alcanzar tu potencial.
En TU desarrollo profesional y personal en GSK, alcanzarás metas de carrera, ya que contarás con todo tipo de iniciativas de desarrollo como el Programa de Futuros Líderes, Programas de Desarrollo de Liderazgo y nuestro compromiso de Coaching.
Si crees que este es el siguiente movimiento en TU carrera, aplica. Tienes hasta el  20/07/2017.

qualifications:
Los empleados GSK son conocidos por saber Trabajar a Través de Fronteras, entendiendo cómo colaborar en ambientes multiculturales y en equipos multifuncionales; siempre orientados a inspirar a aquellos a su alrededor, teniendo un enfoque en su desempeño y creando un ambiente de trabajo sano e inclusivo. Nos caracterizamos por ser positivos y siempre Vivir nuestros Valores.
Ser un empleado GSK te permite generar retos y cambios no sólo en la forma en que manejamos nuestro negocio sino también impactando la forma en que nosotros como personas Desarrollamos nuestras propias Competencias y Talentos.

Nuestra área de Calidad se encuentra en la búsqueda de un Pasante para dar soporte al área en general.
Preferred qualifications:
Para lograr nuestros objetivos nos encontramos en la búsqueda de estudiantes de Ingeniería Industrial, Ingeniería Agroquímica, y/o Agroindustrial que posean un manejo Intermedio - Avanzado de Inglés.

Será valorada experiencia laboral previa.
 


Medical Information Scientist
Description:
To meet the needs of healthcare providers through collaboration with internal business partners to ensure the delivery of accurate and scientifically balanced medical information and to respond to unsolicited inquiries from healthcare professionals (HCPs), including payers and managed healthcare organizations in a manner that will help them make a decision regarding therapy for a patient or product selection.

qualifications:
Doctor of Pharmacy

1 year residency experience or 2 years post-graduate clinical/pharmaceutical industry experience

Proof of pharmacist licensure required
Preferred qualifications:
5+ years experience in clinical practice setting in situations where direct and/or indirect decision making authority for patient care was demonstrated (e.g. direct patient care, treatment protocol development, drug therapy guidelines development, traditional clinical pharmacy practice settings) or within a pharmaceutical industry where medical information (e.g. drug information residency) is verbally shared with healthcare professions.

Competencies to include: understanding of scientific literature analysis to support the provision of medical engagement through written or verbal communication with our medical services staff. Communication and presentation skills. Ability to work independently and manage/prioritize multiple projects simultaneously

Residency and/or post-doctoral training in a clinical practice/pharmaceutical industry setting

Market Access Manager (m/w)
Description:
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
 







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